Trial Outcomes & Findings for Combination Therapy With VRC01 and 10-1074 in HIV-Infected Individuals Undergoing Sequential Treatment Interruptions (NCT NCT03831945)
NCT ID: NCT03831945
Last Updated: 2021-10-12
Results Overview
Number of days from start of the second analytical treatment interruption (ATI) until the subject meets criteria to restart Antiretroviral Therapy (ART) before Week 16 \[a confirmed \>30% decline in baseline CD4+ T Cell count or an absolute CD4+ T Cell count in the setting of detectable HIV viremia (\>40 copies/mL); a sustained (\>4weeks) HIV RNA level of \> 1000 copies/mL, or any HIV related symptoms or pregnancy.\]
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
27 participants
Primary outcome timeframe
From start of second Analytical Treatment Interruption (ATI) until up to 16 weeks
Results posted on
2021-10-12
Participant Flow
27 subjects were consented to protocol. 20 subjects started the study. Five subjects enrolled but not randomized due to the coronavirus disease 2019 (COVID 19) pandemic; one subject was lost to follow-up after enrollment, and one subjects not randomized due to hospitalization.
Participant milestones
| Measure |
Single Infusion of VRC01 and 10-1074
Single infusion of 40 mg/kg VRC-HIVMAB060-00-AB (VRC01) in 100 mL of saline and 30 mg/kg of 10-1074 in 250 mL of saline when viral load is \>/= 200 copies/mL in HIV-infected individuals undergoing antiretroviral treatment interruption.
|
Single Infusion of Normal Saline
Single infusion of 100 mL and 250 mL of normal saline when viral load is \>/= 200 copies/mL in HIV-infected individuals undergoing antiretroviral treatment interruption.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
3
|
4
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
Reasons for withdrawal
| Measure |
Single Infusion of VRC01 and 10-1074
Single infusion of 40 mg/kg VRC-HIVMAB060-00-AB (VRC01) in 100 mL of saline and 30 mg/kg of 10-1074 in 250 mL of saline when viral load is \>/= 200 copies/mL in HIV-infected individuals undergoing antiretroviral treatment interruption.
|
Single Infusion of Normal Saline
Single infusion of 100 mL and 250 mL of normal saline when viral load is \>/= 200 copies/mL in HIV-infected individuals undergoing antiretroviral treatment interruption.
|
|---|---|---|
|
Overall Study
Received study agent, never started second Analytical Treatment Interruption (ATI) due to COVID-19
|
4
|
4
|
|
Overall Study
Received study agent, never started second analytical Treatment Interruption due to unprotected sex
|
1
|
1
|
|
Overall Study
Received study agent, second analytical treatment interruption (ATI) ended early due to COVID-19
|
2
|
1
|
Baseline Characteristics
Combination Therapy With VRC01 and 10-1074 in HIV-Infected Individuals Undergoing Sequential Treatment Interruptions
Baseline characteristics by cohort
| Measure |
Single Infusion of VRC01 and 10-1074
n=10 Participants
Single infusion of 40 mg/kg VRC-HIVMAB060-00-AB (VRC01) in 100 mL of saline and 30 mg/kg of 10-1074 in 250 mL of saline when viral load is \>/= 200 copies/mL in HIV-infected individuals undergoing antiretroviral treatment interruption.
|
Single Infusion of Normal Saline
n=10 Participants
Single infusion of 100 mL and 250 mL of normal saline when viral load is \>/= 200 copies/mL in HIV-infected individuals undergoing antiretroviral treatment interruption.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From start of second Analytical Treatment Interruption (ATI) until up to 16 weeksPopulation: The analyses included all subjects who completed the second analytical treatment interruption phase. Because of safety concerns that stopping treatment for HIV during the current COVID-19 pandemic could increase the risk of getting severe COVID-19, the study was halted before sufficient participants had enrolled and completed the second analytical treatment interruption to accurately determine primary outcome
Number of days from start of the second analytical treatment interruption (ATI) until the subject meets criteria to restart Antiretroviral Therapy (ART) before Week 16 \[a confirmed \>30% decline in baseline CD4+ T Cell count or an absolute CD4+ T Cell count in the setting of detectable HIV viremia (\>40 copies/mL); a sustained (\>4weeks) HIV RNA level of \> 1000 copies/mL, or any HIV related symptoms or pregnancy.\]
Outcome measures
| Measure |
Single Infusion of VRC01 and 10-1074
n=3 Participants
Single infusion of 40 mg/kg VRC-HIVMAB060-00-AB (VRC01) in 100 mL of saline and 30 mg/kg of 10-1074 in 250 mL of saline when viral load is \>/= 200 copies/mL in HIV-infected individuals undergoing antiretroviral treatment interruption.
|
Single Infusion of Normal Saline
n=4 Participants
Single infusion of 100 mL and 250 mL of normal saline when viral load is \>/= 200 copies/mL in HIV-infected individuals undergoing antiretroviral treatment interruption.
|
|---|---|---|
|
Days From Start of the Second Treatment Interruption Until the Subject Meets Criteria to Restart ART
|
57 Days
Interval 50.5 to 59.0
|
63 Days
Interval 51.25 to 78.5
|
SECONDARY outcome
Timeframe: From the start of the initial infusion through follow-up phase week 24Population: The analyses included all subjects who received at least one infusion of study agent
Percent of participants with grade 3 or higher adverse events, including serious adverse events, that were probably or definitely related to study agent
Outcome measures
| Measure |
Single Infusion of VRC01 and 10-1074
n=10 Participants
Single infusion of 40 mg/kg VRC-HIVMAB060-00-AB (VRC01) in 100 mL of saline and 30 mg/kg of 10-1074 in 250 mL of saline when viral load is \>/= 200 copies/mL in HIV-infected individuals undergoing antiretroviral treatment interruption.
|
Single Infusion of Normal Saline
n=10 Participants
Single infusion of 100 mL and 250 mL of normal saline when viral load is \>/= 200 copies/mL in HIV-infected individuals undergoing antiretroviral treatment interruption.
|
|---|---|---|
|
Percent of Participants With Grade 3 or Higher Related Adverse Events
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
Single Infusion of VRC01 and 10-1074
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Single Infusion of Normal Saline
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Single Infusion of VRC01 and 10-1074
n=10 participants at risk
Single infusion of 40 mg/kg VRC-HIVMAB060-00-AB (VRC01) in 100 mL of saline and 30 mg/kg of 10-1074 in 250 mL of saline when viral load is \>/= 200 copies/mL in HIV-infected individuals undergoing antiretroviral treatment interruption.
|
Single Infusion of Normal Saline
n=10 participants at risk
Single infusion of 100 mL and 250 mL of normal saline when viral load is \>/= 200 copies/mL in HIV-infected individuals undergoing antiretroviral treatment interruption.
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
10.0%
1/10 • After administration of study agent through follow-up phase week 24
|
0.00%
0/10 • After administration of study agent through follow-up phase week 24
|
|
Hepatobiliary disorders
Cholelithiasis
|
10.0%
1/10 • After administration of study agent through follow-up phase week 24
|
0.00%
0/10 • After administration of study agent through follow-up phase week 24
|
Other adverse events
| Measure |
Single Infusion of VRC01 and 10-1074
n=10 participants at risk
Single infusion of 40 mg/kg VRC-HIVMAB060-00-AB (VRC01) in 100 mL of saline and 30 mg/kg of 10-1074 in 250 mL of saline when viral load is \>/= 200 copies/mL in HIV-infected individuals undergoing antiretroviral treatment interruption.
|
Single Infusion of Normal Saline
n=10 participants at risk
Single infusion of 100 mL and 250 mL of normal saline when viral load is \>/= 200 copies/mL in HIV-infected individuals undergoing antiretroviral treatment interruption.
|
|---|---|---|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/10 • After administration of study agent through follow-up phase week 24
|
10.0%
1/10 • After administration of study agent through follow-up phase week 24
|
|
Gastrointestinal disorders
Salivary gland disorder
|
10.0%
1/10 • After administration of study agent through follow-up phase week 24
|
0.00%
0/10 • After administration of study agent through follow-up phase week 24
|
|
General disorders
Chest pain
|
10.0%
1/10 • After administration of study agent through follow-up phase week 24
|
0.00%
0/10 • After administration of study agent through follow-up phase week 24
|
|
General disorders
Chills
|
0.00%
0/10 • After administration of study agent through follow-up phase week 24
|
10.0%
1/10 • After administration of study agent through follow-up phase week 24
|
|
General disorders
Fatigue
|
0.00%
0/10 • After administration of study agent through follow-up phase week 24
|
20.0%
2/10 • After administration of study agent through follow-up phase week 24
|
|
General disorders
Malaise
|
0.00%
0/10 • After administration of study agent through follow-up phase week 24
|
10.0%
1/10 • After administration of study agent through follow-up phase week 24
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/10 • After administration of study agent through follow-up phase week 24
|
10.0%
1/10 • After administration of study agent through follow-up phase week 24
|
|
General disorders
Pain
|
10.0%
1/10 • After administration of study agent through follow-up phase week 24
|
0.00%
0/10 • After administration of study agent through follow-up phase week 24
|
|
General disorders
Tenderness
|
10.0%
1/10 • After administration of study agent through follow-up phase week 24
|
0.00%
0/10 • After administration of study agent through follow-up phase week 24
|
|
Infections and infestations
COVID-19
|
0.00%
0/10 • After administration of study agent through follow-up phase week 24
|
10.0%
1/10 • After administration of study agent through follow-up phase week 24
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/10 • After administration of study agent through follow-up phase week 24
|
10.0%
1/10 • After administration of study agent through follow-up phase week 24
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/10 • After administration of study agent through follow-up phase week 24
|
10.0%
1/10 • After administration of study agent through follow-up phase week 24
|
|
Infections and infestations
Gonorrhoea
|
10.0%
1/10 • After administration of study agent through follow-up phase week 24
|
0.00%
0/10 • After administration of study agent through follow-up phase week 24
|
|
Infections and infestations
Nasopharyngitis
|
30.0%
3/10 • After administration of study agent through follow-up phase week 24
|
20.0%
2/10 • After administration of study agent through follow-up phase week 24
|
|
Infections and infestations
Skin infection
|
10.0%
1/10 • After administration of study agent through follow-up phase week 24
|
0.00%
0/10 • After administration of study agent through follow-up phase week 24
|
|
Infections and infestations
Syphilis
|
10.0%
1/10 • After administration of study agent through follow-up phase week 24
|
0.00%
0/10 • After administration of study agent through follow-up phase week 24
|
|
Infections and infestations
Tooth infection
|
0.00%
0/10 • After administration of study agent through follow-up phase week 24
|
10.0%
1/10 • After administration of study agent through follow-up phase week 24
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
1/10 • After administration of study agent through follow-up phase week 24
|
0.00%
0/10 • After administration of study agent through follow-up phase week 24
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/10 • After administration of study agent through follow-up phase week 24
|
10.0%
1/10 • After administration of study agent through follow-up phase week 24
|
|
Injury, poisoning and procedural complications
Injury
|
10.0%
1/10 • After administration of study agent through follow-up phase week 24
|
10.0%
1/10 • After administration of study agent through follow-up phase week 24
|
|
Injury, poisoning and procedural complications
Muscle strain
|
10.0%
1/10 • After administration of study agent through follow-up phase week 24
|
0.00%
0/10 • After administration of study agent through follow-up phase week 24
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/10 • After administration of study agent through follow-up phase week 24
|
10.0%
1/10 • After administration of study agent through follow-up phase week 24
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/10 • After administration of study agent through follow-up phase week 24
|
40.0%
4/10 • After administration of study agent through follow-up phase week 24
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/10 • After administration of study agent through follow-up phase week 24
|
20.0%
2/10 • After administration of study agent through follow-up phase week 24
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/10 • After administration of study agent through follow-up phase week 24
|
10.0%
1/10 • After administration of study agent through follow-up phase week 24
|
|
Investigations
Blood glucose increased
|
0.00%
0/10 • After administration of study agent through follow-up phase week 24
|
10.0%
1/10 • After administration of study agent through follow-up phase week 24
|
|
Investigations
Echocardiogram abnormal
|
0.00%
0/10 • After administration of study agent through follow-up phase week 24
|
10.0%
1/10 • After administration of study agent through follow-up phase week 24
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/10 • After administration of study agent through follow-up phase week 24
|
10.0%
1/10 • After administration of study agent through follow-up phase week 24
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/10 • After administration of study agent through follow-up phase week 24
|
10.0%
1/10 • After administration of study agent through follow-up phase week 24
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/10 • After administration of study agent through follow-up phase week 24
|
10.0%
1/10 • After administration of study agent through follow-up phase week 24
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
10.0%
1/10 • After administration of study agent through follow-up phase week 24
|
0.00%
0/10 • After administration of study agent through follow-up phase week 24
|
|
Nervous system disorders
Ageusia
|
0.00%
0/10 • After administration of study agent through follow-up phase week 24
|
10.0%
1/10 • After administration of study agent through follow-up phase week 24
|
|
Nervous system disorders
Anosmia
|
0.00%
0/10 • After administration of study agent through follow-up phase week 24
|
10.0%
1/10 • After administration of study agent through follow-up phase week 24
|
|
Nervous system disorders
Headache
|
0.00%
0/10 • After administration of study agent through follow-up phase week 24
|
20.0%
2/10 • After administration of study agent through follow-up phase week 24
|
|
Psychiatric disorders
Depression
|
10.0%
1/10 • After administration of study agent through follow-up phase week 24
|
0.00%
0/10 • After administration of study agent through follow-up phase week 24
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/10 • After administration of study agent through follow-up phase week 24
|
10.0%
1/10 • After administration of study agent through follow-up phase week 24
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10 • After administration of study agent through follow-up phase week 24
|
10.0%
1/10 • After administration of study agent through follow-up phase week 24
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/10 • After administration of study agent through follow-up phase week 24
|
10.0%
1/10 • After administration of study agent through follow-up phase week 24
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/10 • After administration of study agent through follow-up phase week 24
|
10.0%
1/10 • After administration of study agent through follow-up phase week 24
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
10.0%
1/10 • After administration of study agent through follow-up phase week 24
|
0.00%
0/10 • After administration of study agent through follow-up phase week 24
|
|
Social circumstances
Dental prosthesis user
|
10.0%
1/10 • After administration of study agent through follow-up phase week 24
|
0.00%
0/10 • After administration of study agent through follow-up phase week 24
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/10 • After administration of study agent through follow-up phase week 24
|
10.0%
1/10 • After administration of study agent through follow-up phase week 24
|
Additional Information
Sneller, Michael
National Institute of Allergy and Infectious Diseases
Phone: +1 301 496 0491
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place